510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+9K151216Everest Spinal SystemK2m, Inc.201511—
+9K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+9K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+9K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+9K133402K2M Modular HooksK2m, Inc.20140—
+9K141217Acculif TL and PL CageStryker Corporation20146423
+9K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K263049SABER-C SystemElevation Spine20260—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+10K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+10K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+10K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+10K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+10K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+10K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+10K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+10K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+10K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+10K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+10K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+10K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+10K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+10K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+10K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+10K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+10K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+10K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+10K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+10K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+10K181014Tritanium PL CageStryker Spine2018137—
+10K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+10K181188EVEREST Spinal SystemK2m, Inc.20186—
+10K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+10K171321K2M Navigation InstrumentsK2m201711
+10K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+10K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+10K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+10K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+10K152622Alta ACDF SystemBiomet Spine20160—
+10K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+11K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+11K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+11K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+11K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+11K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+11K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+11K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+11K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+11K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—